Devices, systems, and methods for medicament delivery

ABSTRACT

Certain exemplary embodiments comprise can comprise an auto-injector, which can comprise: a vial configured to store and/or contain an injectable medicament, the vial defining a vial longitudinal axis, and a housing comprising the vial. In various embodiments, the injectable medicament can be a medicine, medication, drug, pharmaceutical, prescriptive, agent, antidote, anti-venom, hormone, stimulant, vasodilator, anesthetic, and/or nutritional supplement that is substantially ready for injection.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/244,311, entitled “Devices, Systems, and Methods for MedicamentDelivery,” filed Apr. 3, 2014, which is a continuation of U.S. patentapplication Ser. No. 12/818,496, now U.S. Pat. No. 8,690,827, entitled“Devices, Systems, and Methods for Medicament Delivery,” filed Jun. 18,2010, which is a continuation of U.S. patent application Ser. No.10/572,148, now U.S. Pat. No. 7,749,194, entitled “Devices, Systems, andMethods for Medicament Delivery,” filed Mar. 16, 2006, which is anational stage filing under 35 U.S.C. § 371 of International PatentApplication No. PCT/US06/03415, entitled “Devices, Systems, and Methodsfor Medicament Delivery,” filed Feb. 1, 2006, which claims priority toU.S. Provisional Application Ser. No. 60/731,886, entitled“Auto-injector with Feedback” filed Oct. 31, 2005, each of which isincorporated herein by reference in its entirety. International PatentApplication No. PCT/US06/03415 claims priority to U.S. ProvisionalApplication Ser. No. 60/648,822 entitled “Devices, Systems, and Methodsfor Medicament Delivery,” filed Feb. 1, 2005, which is incorporatedherein by reference in its entirety.

BRIEF DESCRIPTION OF THE DRAWINGS

A wide variety of potential embodiments will be more readily understoodthrough the following detailed description of certain exemplaryembodiments, with reference to the accompanying exemplary drawings inwhich:

FIG. 1 is a perspective view of an exemplary embodiment of a system1000;

FIG. 2 is a front view of an exemplary embodiment of a system 1000;

FIG. 3 is a side view of an exemplary embodiment of a system 1000;

FIG. 4 is a cross-sectional view taken along lines A-A of FIG. 3 of anexemplary embodiment of a system 1000 in a first operative position;

FIG. 5 is a cross-sectional view taken along lines A-A of FIG. 3 of anexemplary embodiment of a system 1000 in a second operative position;

FIG. 6 is a cross-sectional view taken along lines A-A of FIG. 3 of anexemplary embodiment of a system 1000 in a third operative position;

FIG. 7 is a cross-sectional view taken along lines A-A of FIG. 3 of anexemplary embodiment of a system 1000 in a fourth operative position;

FIG. 8 is a cross-sectional view taken along lines A-A of FIG. 3 of anexemplary embodiment of a system 1000 in a fifth operative position;

FIG. 9 is a cross-sectional view taken along lines A-A of FIG. 3 of anexemplary embodiment of a system 1000 in a sixth operative position;

FIG. 10 is a flowchart of an exemplary embodiment of a method 10000;

FIG. 11 is a perspective view of an exemplary embodiment of system 1000;

FIG. 12 is a perspective cross-sectional view taken along lines B-B ofFIG. 11;

FIG. 13 is a perspective view of an exemplary embodiment of actuationstick 2200;

FIG. 14 is a cross-sectional view of an exemplary embodiment of gasventing mechanism 8000 taken along lines A-A of FIG. 3;

FIG. 15 is a cross-sectional view taken along lines A-A of FIG. 3 of anexemplary embodiment of a system 15000;

FIG. 16 is a perspective view of an exemplary embodiment anauto-injector 16000;

FIG. 17 is a cross-sectional view taken along lines A-A of FIG. 3 of anexemplary embodiment of a system 17000;

FIG. 18A is an end view of an exemplary embodiment of a system 18000;

FIG. 18B is a cross-sectional view taken along lines A-A of FIG. 18A ofan exemplary embodiment of a system 18000;

FIG. 19 is a cross-sectional view taken along lines A-A of FIG. 18A ofan exemplary embodiment of a system 19000;

FIG. 20 is a cross-sectional view taken along lines A-A of FIG. 18A ofan exemplary embodiment of a system 20000;

FIG. 21A is a cross-sectional view taken along lines A-A of FIG. 18A ofan exemplary embodiment of a system 21000;

FIG. 21B is a front view of an exemplary embodiment of a system 21000;

FIG. 22A is a cross-sectional view taken along lines A-A of FIG. 18A ofan exemplary embodiment of a system 22000;

FIG. 22B is a front view of an exemplary embodiment of a system 22500;

FIG. 23 is a cross-sectional view taken along lines A-A of FIG. 18A ofan exemplary embodiment of a system 23000;

FIG. 24 is a perspective view of an exemplary embodiment anauto-injector 24000;

FIG. 25 is a perspective view of an exemplary embodiment anauto-injector 25000; and

FIG. 26 is a block diagram of an exemplary embodiment an informationdevice 26000.

DETAILED DESCRIPTION Definitions

When the following terms are used substantively herein, the accompanyingdefinitions apply:

a—at least one.

activate—to actuate and/or set in motion and/or action.

activity—an action, act, step, and/or process or portion thereof.

actuating portion—that part that puts something into action.

actuation lock—a device adapted to prevent actuation, such as, forexample a pivotable, translatable, keyed, squeezable, and/or removablelock.

actuator—a mechanism that puts something into action.

adapted to—suitable or fit for a particular purpose.

and/or—either in conjunction with or in alternative to.

apparatus—a mechanism and/or device.

arm—an elongated structural member, which need not be solely linear.

auto-injector—device that allows a user to deliver a medicament withouthaving to manually prepare the injection. Exemplary devices include pendelivered injectors, syringes, needleless injectors, gas poweredauto-injectors, and/or any other auto-injector and/or medical deviceused to inject a medicament into a user/patient, etc.

automatically—acting or operating in a manner essentially independent ofexternal influence or control. For example, an automatic light switchcan turn on upon “seeing” a person in its view, without the personmanually operating the light switch.

axis—a straight line about which a body or geometric object rotates ormay be conceived to rotate.

can—is capable of, in at least some embodiments.

channel—a conduit for one or more fluids.

compressed gas—a substantially pressurized substance, such as helium,nitrogen, and/or carbon dioxide, etc., in a gaseous form.

comprising—including but not limited to.

contain—to hold within.

contents—a contained compressed gas.

credit card—a card (usually plastic) that assures a seller that theperson using it has a satisfactory credit rating and that the issuerwill see to it that the seller receives payment for the merchandiseand/or services delivered. Typically measuring in size fromapproximately 3 to approximately 4 inches in length, such asapproximately 3.40 inches, 3.375 inches, 85 millimeters, etc., and fromapproximately 1.75 to approximately 2.75 inches in width, such asapproximately 2.10 inches, 2.2125 inches, 2.5 inches, 55 millimeters,etc.

data—distinct pieces of information, usually formatted in a special orpredetermined way and/or organized to express concepts.

define—to establish the outline, form, or structure of.

device—a machine, manufacture, and/or collection thereof.

discharge—to release from confinement; to emit.

driving force—a force sufficient to cause, directly or indirectly,expulsion of an injectable medicament from one or more vials and/or froman auto-injector.

dry substance—a material that is substantially free from liquid ormoisture.

eject—to expel.

embedded system—a programmed hardware device comprising a microprocessorcontrolled by an operating system and/or control logic that isspecifically designed for a particular kind of application. Theoperating system and/or control logic of an embedded system comprises alimited set of pre-defined functions that cannot be modified or added toby additional user-installed software, although some embedded systemsallow a user to modify values of variables and/or parameters of thepre-defined functions. Exemplary devices that can comprise embeddedsystems are: medical devices, calculators, automobiles, airplanes,vending machines, toys, programmable logic controllers, appliances,refrigerators, microwave ovens, clothes washers, thermostats, alarmsystems, sprinkler systems, lighting controllers, electronic equipment,laser printers, CD players, DVD players, watches, and/or digitalcameras, etc.

escape port—an opening for the exit of a gas.

expulsion—the act of forcibly ejecting a fluid via a designed outlet ofa container.

expulsion pressure—a force applied over an area of a liquid, the forcesufficient to expel the liquid in a predetermined manner.

extend—to move out and/or away from.

extendable—able to move out and/or away from.

fluid—a gas and/or liquid.

fluidly coupleable—able to be related via a fluid.

force initiator—a source, such as a compressed gas container, spring,and/or chemical reaction, etc., capable of supplying a driving force.

frangible—a device that is capable of being broken and/or penetrated toallow fluid to flow therethrough.

haptic—involving the human sense of kinesthetic movement and/or thehuman sense of touch. Among the many potential haptic experiences arenumerous sensations, body-positional differences in sensations, andtime-based changes in sensations that are perceived at least partiallyin non-visual, non-audible, and non-olfactory manners, including theexperiences of tactile touch (being touched), active touch, grasping,pressure, friction, traction, slip, stretch, force, torque, impact,puncture, vibration, motion, acceleration, jerk, pulse, orientation,limb position, gravity, texture, gap, recess, viscosity, pain, itch,moisture, temperature, thermal conductivity, and thermal capacity.

hard real-time—relating to computer systems that provide an absolutedeterministic response to an event. Such a response is not based onaverage event time. Instead, in such computer systems, the deadlines arefixed and the system must guarantee a response within a fixed andwell-defined time. Systems operating in hard real-time typicallyinteract at a low level with physical hardware via embedded systems, andcan suffer a critical failure if time constraints are violated. Aclassic example of a hard real-time computing system is the anti-lockbrakes on a car. The hard real-time constraint, or deadline, in thissystem is the time in which the brakes must be released to prevent thewheel from locking. Another example is a car engine control system, inwhich a delayed control signal might cause engine failure or damage.Other examples of hard real-time embedded systems include medicalsystems such as heart pacemakers and industrial process controllers.

hazardous condition—a situation marked by risk, danger, and/or peril.

housing—something that covers, encloses, protects, holds, and/orsupports.

in reaction to—responding indirectly and/or directly to.

indicate—to show, mark, signify, denote, evidence, evince, manifest,declare, enunciate, specify, explain, exhibit, present, reveal,disclose, and/or display.

indicator—a device and/or substance that indicates.

information device—any device capable of processing information, such asany general purpose and/or special purpose computer, such as a personalcomputer, workstation, server, minicomputer, mainframe, supercomputer,computer terminal, laptop, wearable computer, and/or Personal DigitalAssistant (PDA), mobile terminal, Bluetooth device, communicator,“smart” phone (such as a Treo-like device), messaging service (e.g.,Blackberry) receiver, pager, facsimile, cellular telephone, atraditional telephone, telephonic device, a programmed microprocessor ormicrocontroller and/or peripheral integrated circuit elements, an ASICor other integrated circuit, a hardware electronic logic circuit such asa discrete element circuit, and/or a programmable logic device such as aPLD, PLA, FPGA, or PAL, or the like, etc. In general any device on whichresides a finite state machine capable of implementing at least aportion of a method, structure, and/or or graphical user interfacedescribed herein may be used as an information device. An informationdevice can comprise components such as one or more network interfaces,one or more processors, one or more memories containing instructions,and/or one or more input/output (I/O) devices, one or more userinterfaces coupled to an I/O device, etc.

injectable medicament—a medicine, medication, drug, pharmaceutical,prescriptive, agent, antidote, anti-venom, hormone, stimulant,vasodilator, anesthetic, and/or nutritional supplement that issubstantially ready for injection.

input/output (I/O) device—any sensory-oriented input and/or outputdevice, such as an audio, visual, haptic, olfactory, and/ortaste-oriented device, including, for example, a monitor, display,projector, overhead display, keyboard, keypad, mouse, trackball,joystick, gamepad, wheel, touchpad, touch panel, pointing device,microphone, speaker, video camera, camera, scanner, printer, hapticdevice, vibrator, tactile simulator, and/or tactile pad, potentiallyincluding a port to which an I/O device can be attached or connected.

liquid—a body of matter that exhibits a characteristic readiness toflow, little or no tendency to disperse, and relatively highincompressibility.

longitudinal—of or relating to longitude or length.

machine instructions—directions adapted to cause a machine, such as aninformation device, to perform a particular operation or function.

machine readable medium—a physical structure from which a machine canobtain data and/or information. Examples include a memory, punch cards,etc.

may—is allowed to, in at least some embodiments.

memory device—an apparatus capable of storing analog or digitalinformation, such as instructions and/or data. Examples include anonvolatile memory, volatile memory, Random Access Memory, RAM, ReadOnly Memory, ROM, flash memory, magnetic media, a hard disk, a floppydisk, a magnetic tape, an optical media, an optical disk, a compactdisk, a CD, a digital versatile disk, a DVD, and/or a raid array, etc.The memory device can be coupled to a processor and/or can storeinstructions adapted to be executed by processor, such as according toan embodiment disclosed herein.

method—a process, procedure, and/or collection of related activities foraccomplishing something.

microprocessor—an integrated circuit comprising a central processingunit.

mixable—dissolvable, dispersible, and/or capable of being put into sothat the dry substance is diffused and/or commingled in the liquid.

needle—a hollow, slender, sharp-pointed instrument used for injection.Includes cannulas.

network—a communicatively coupled plurality of nodes.

network interface—any device, system, or subsystem capable of couplingan information device to a network. For example, a network interface canbe a telephone, cellular phone, cellular modem, telephone data modem,fax modem, wireless transceiver, ethernet card, cable modem, digitalsubscriber line interface, bridge, hub, router, or other similar device.

non-co-axial—not having co-linear axes.

output device—an apparatus configured to visually, audibly, and/orhaptically render information to a human. Examples include an audibleoutput sub-system (e.g., speaker, horn, buzzer, and/or piezoelectrictransducer, etc.), a visual output sub-system (e.g., flag, marker,light, liquid crystal display (LCD), light emitting diode (LED), opticalfiber, organic polymer display, electric paper, screen, display,monitor, and/or tube, etc.), and a haptic output sub-system (e.g.,buzzer, vibrator, bulging portion, tactile stimulator, cooler, and/orheater, etc.), etc.

patient—a receiver of an injectable medicament, such as a human, mammal,animal, etc.

piston—a sliding piece which either is moved by, or moves against, fluidpressure.

pivotable—capable of pivoting.

plurality—the state of being plural and/or more than one.

predetermined—established in advance.

processor—a device and/or set of machine-readable instructions forperforming one or more predetermined tasks. A processor can comprise anyone or a combination of hardware, firmware, and/or software. A processorcan utilize mechanical, pneumatic, hydraulic, electrical, magnetic,optical, informational, chemical, and/or biological principles, signals,and/or inputs to perform the task(s). In certain embodiments, aprocessor can act upon information by manipulating, analyzing,modifying, converting, transmitting the information for use by anexecutable procedure and/or an information device, and/or routing theinformation to an output device. A processor can function as a centralprocessing unit, local controller, remote controller, parallelcontroller, and/or distributed controller, etc. Unless stated otherwise,the processor can be a general-purpose device, such as a microcontrollerand/or a microprocessor, such the Pentium IV series of microprocessormanufactured by the Intel Corporation of Santa Clara, Calif. In certainembodiments, the processor can be dedicated purpose device, such as anApplication Specific Integrated Circuit (ASIC) or a Field ProgrammableGate Array (FPGA) that has been designed to implement in its hardwareand/or firmware at least a part of an embodiment disclosed herein.

programmable logic controller (PLC)—a solid-state, microprocessor-based,hard real-time computing system that is used, via a network, toautomatically monitor the status of field-connected sensor inputs, andautomatically control communicatively-coupled devices of a controlledsystem (e.g., actuators, solenoids, relays, switches, motor starters,speed drives (e.g., variable frequency drives, silicon-controlledrectifiers, etc.), pilot lights, ignitors, speakers, tape drives,printers, monitors, displays, etc.) according to a user-created set ofvalues and user-created logic and/or instructions stored in memory. Thesensor inputs reflect measurements and/or status information related tothe controlled system. A PLC provides any of: automated input/outputcontrol; switching; counting; arithmetic operations; complex datamanipulation; logic; timing; sequencing; communication; data filemanipulation; report generation; control; relay control; motion control;process control; distributed control; and/or monitoring of processes,equipment, and/or other automation of the controlled system. Because ofits precise and hard real-time timing and sequencing capabilities, a PLCis programmed using ladder logic or some form of structured programminglanguage specified in IEC 61131-3, namely, FBD (Function Block Diagram),LD (Ladder Diagram), ST (Structured Text, Pascal type language), IL(Instruction List) and/or SFC (Sequential Function Chart). Because ofits precise and real-time timing and sequencing capabilities, a PLC canreplace up to thousands of relays and cam timers. PLC hardware often hasgood redundancy and fail-over capabilities. A PLC can use aHuman-Machine Interface (HMI) for interacting with users forconfiguration, alarm reporting, and/or control.

puncturer—a device adapted to penetrate using a substantially sharpand/or tapered point, tip, edge, or the like.

pusher—a device adapted to convert fluid pressure to mechanicalmovement.

render—make perceptible to a human, for example as data, commands, text,graphics, audio, video, animation, and/or hyperlinks, etc., such as viaany visual, audio, and/or haptic means, such as via a display, monitor,electric paper, ocular implant, cochlear implant, speaker, etc.

repeatedly—again and again; repetitively.

reservoir—a receptacle or chamber for storing and/or directing movementof a fluid.

resist—to avoid and/or remain firm against the actions, effects, and/orforce of.

retract—to pull inward.

safety tab—a removable device configured to prevent actuation of anauto-injector when the safety tab is in one orientation, and allowactuation when in another orientation.

sensed variable—a measured parameter.

set—a related plurality.

sheath—a protective cover.

shield—a protective device or structure.

soft real-time—relating to computer systems that take a best effortsapproach and minimize latency from event to response as much as possiblewhile keeping throughput up with external events overall. Such systemswill not suffer a critical failure if time constraints are violated. Forexample, live audio-video systems are usually soft real-time; violationof time constraints can result in degraded quality, but the system cancontinue to operate. Another example is a network server, which is asystem for which fast response is desired but for which there is nodeadline. If the network server is highly loaded, its response time mayslow with no failure in service. This is contrasted with the anti-lockbraking system where a slow down in response would likely cause systemfailure, possibly even catastrophic failure.

spring—an elastic device, such as a coil of wire, that regains itsoriginal shape after being compressed or extended.

status—a state or condition.

store—to place, hold, and/or retain data, typically in a memory.

substantially—to a great extent or degree.

system—a collection of mechanisms, devices, data, and/or instructions,the collection designed to perform one or more specific functions.

tip—a terminal end.

transfer—to convey from one place to another.

translatable—capable of being transferred from one place to anotherand/or of being moved with respect to something else.

triggerable—capable of being actuated.

use indication—information regarding a use of an auto-injector, such asinformation regarding any of auto-injector selection; auto-injectormaintenance; auto-injector expiration; auto-injector replacement;medicament expiration; medicament selection; medicament mixing;injection delay; safety guard removal; auto-injector positioning;auto-injector orientation; actuator location; injection hazardavoidance; auto-injector actuation; injection duration; injectionstatus; injection error; auto-injector removal; auto-injector reuse;auto-injector recycling; and auto-injector disposal, etc.

user input—human-provided information.

user interface—any device for rendering information to a user and/orrequesting information from the user. A user interface includes at leastone of textual, graphical, audio, video, animation, and/or hapticelements. A textual element can be provided, for example, by a printer,monitor, display, projector, etc. A graphical element can be provided,for example, via a monitor, display, projector, and/or visual indicationdevice, such as a light, flag, beacon, etc. An audio element can beprovided, for example, via a speaker, microphone, and/or other soundgenerating and/or receiving device. A video element or animation elementcan be provided, for example, via a monitor, display, projector, and/orother visual device. A haptic element can be provided, for example, viaa very low frequency speaker, vibrator, tactile stimulator, tactile pad,simulator, keyboard, keypad, mouse, trackball, joystick, gamepad, wheel,touchpad, touch panel, pointing device, and/or other haptic device, etc.A user interface can include one or more textual elements such as, forexample, one or more letters, number, symbols, etc. A user interface caninclude one or more graphical elements such as, for example, an image,photograph, drawing, icon, window, title bar, panel, sheet, tab, drawer,matrix, table, form, calendar, outline view, frame, dialog box, statictext, text box, list, pick list, pop-up list, pull-down list, menu, toolbar, dock, check box, radio button, hyperlink, browser, button, control,palette, preview panel, color wheel, dial, slider, scroll bar, cursor,status bar, stepper, and/or progress indicator, etc. A textual and/orgraphical element can be used for selecting, programming, adjusting,changing, specifying, etc. an appearance, background color, backgroundstyle, border style, border thickness, foreground color, font, fontstyle, font size, alignment, line spacing, indent, maximum data length,validation, query, cursor type, pointer type, autosizing, position,and/or dimension, etc. A user interface can include one or more audioelements such as, for example, a volume control, pitch control, speedcontrol, voice selector, and/or one or more elements for controllingaudio play, speed, pause, fast forward, reverse, etc. A user interfacecan include one or more video elements such as, for example, elementscontrolling video play, speed, pause, fast forward, reverse, zoom-in,zoom-out, rotate, and/or tilt, etc. A user interface can include one ormore animation elements such as, for example, elements controllinganimation play, pause, fast forward, reverse, zoom-in, zoom-out, rotate,tilt, color, intensity, speed, frequency, appearance, etc. A userinterface can include one or more haptic elements such as, for example,elements utilizing tactile stimulus, force, pressure, vibration, motion,displacement, temperature, etc.

valve—a device that regulates flow through a pipe and/or through anaperture by opening, closing, and/or obstructing a port and/orpassageway.

vent—to release from confinement.

via—by way of and/or utilizing.

vial—a closable vessel.

DETAILED DESCRIPTION

Exposure, such as via ingestion, inhalation, and/or injection, tocertain allergens, toxins, and/or other substances can cause profoundreactions for some and/or all people and/or animals. For example,certain people are highly allergic to certain substances, such aspeanuts, shellfish, particular drugs, certain proteins, bee venom,insect bites, etc. The allergic response to the exposure can lead toanaphylactic shock, which can cause a sharp drop in blood pressure,hives, and/or substantial breathing difficulties caused by severe airwayconstriction. As another example, inhalation of certain nerve agents cancause severe physiological trauma. Responding rapidly to such exposurescan prevent injury and/or death. For example, in response to an exposureleading to anaphylactic shock, an injection of epinephrine (i.e.,adrenaline) can provide substantial and/or complete relief from thereaction. As another example, injection of an antidote to a nerve agentcan greatly reduce and/or eliminate the potential harm of the exposure.As yet another example, rapid injection of certain drugs, such as a betablocker, blood thinner, nitroglycerine, antihistamines, insulin, andopioids, etc., can provide substantial relief from various dangerousmedical conditions.

Thus, certain exemplary embodiments provide systems, devices, and/ormethods for rapidly injecting a medicament.

Certain exemplary embodiments comprise an apparatus, comprising: acompressed gas container; a plurality of vials adapted to store a liquidmedicament, each vial defining a longitudinal axis, the longitudinalaxes of the plurality of vials parallel and non-co-axial, the pluralityof vials fluidly coupleable to an actuating portion of a contents of thegas container; and a plurality of pistons, each piston adapted to movewithin a corresponding vial from the plurality of vials, the pluralityof pistons adapted to, in response to discharge of the actuating portionof the contents of the compressed gas container, transfer at least aportion of the liquid medicament from the plurality of vials and througha needle that is extendable into a patient. Certain exemplaryembodiments comprise a method comprising a plurality of activities,comprising: discharging an actuating portion of a contents of acompressed gas container, the compressed gas container contained withinan apparatus; in reaction to said discharging activity, moving a pistonwithin a vial, the vial one of a plurality of vials contained within theapparatus, each vial adapted to store a liquid medicament, each vialdefining a longitudinal axis, the longitudinal axes of the plurality ofvials parallel and non-co-axial, the plurality of vials fluidlycoupleable to a contents of the gas container; and transferring a liquidmedicament from the vial and through a needle that is extendable into apatient.

FIG. 1 is a perspective view, FIG. 2 is a front view, and FIG. 3 is aside view, of an exemplary embodiment of a system 1000, which cancomprise a housing 1100, which, in certain operative embodiments, cancomprise a handheld portion 1800 separated via an actuation guard 1200from an actuation bar 1300. Actuation guard 1200 can prevent accidentactivation of system 1000. Housing 1100 can be constructed of a durablematerial, such as stainless steel, aluminum, polycarbonate, etc., toprotect a compressed gas container, medicament, injection apparatusand/or user of system 1000. The injection apparatus can be actuated by afluid pressure, such as pressure provided by the compressed gas, whichupon completion of its actuation duties can escape housing 1100 via gasescape opening, such as via status indicator 1400.

A status of a system 1000 can be determined via status indicator 1400,which can provide a view, such as via a UV blocking, photo-sensitive,and/or translucent window, into an interior of housing 1100. Viewablethrough the window can be a status of medicament carried by housing1100, a location of a needle and/or injection apparatus for themedicament, and/or an activation status of system 1000. For example, ifthe medicament has aged to the point of discoloration, which aging mightor might not render the medication useless, harmful, etc., statusindicator 1400 can allow that situation to be determined. In certainexemplary embodiments, gas can escape housing 1100 via status indicator1400 and/or another opening in housing 1100.

Certain exemplary embodiments of system 1000 can provide a compactmedicament delivery mechanism that can efficiently and/or rapidlydeliver a prescribed dose. The length (L) and width (W) of system 1000can be similar to that of a credit card, and the thickness (T) can beless than one inch. Thus, certain exemplary embodiments of system 1000can provide a conveniently carried, easy-to-use, easy to activate drugdelivery apparatus that can require little to no training to safelycarry, use, and/or dispose of.

To assist a user in positioning system 1000 in a correct orientation forinjection, system 1000 and/or housing 1100 can provide various tactileclues. For example, a top 1110 of housing 1100 can be rounded, and abottom 1120 of actuation bar 1300 of housing 1100 can be flat. Othertactile clues are also possible, such as bulges, ribs, grooves, gaps,roughened surfaces, indentations, etc.

FIG. 4 is a cross-sectional view taken along lines A-A of FIG. 3 of anexemplary embodiment of a system 1000 in a first operative position.FIGS. 5, 6, 7, 8, and 9 show system 1000 of FIG. 4 in second, third,fourth, fifth, and sixth operative positions, respectively.

System 1000 can comprise a housing 1100, handheld portion 1800,actuation guard 1200, and/or actuation bar 1300. System 1000 cancomprise system actuator 2000, gas reservoirs 3000, medicament actuator4000, medicament storage assembly 5000, medicament carrier 9000, needleassembly 6000, use indicator 7000, and/or gas vent mechanism 8000, etc.

Upon removal, release, rotation, and/or relocation of actuation guard1200, system actuator 2000 can be adapted to rapidly discharge anactuating portion of a contents of a compress gas container. Forexample, system actuator 2000 can comprise a compressed gas container2400, which initially can contain a compressed gas 2500, an actuatingportion of which can be released from container 2400 by penetration of agas port 2600 via a point of a puncturer 2700. Upon removal and/orrelocation of actuation guard 1200, actuation bar 1300 can be movedcloser to and/or in contact with handheld portion 1800. Upon removaland/or relocation of actuation guard 1200, gas container 2400 can bebrought into contact with puncturer 2700 via extension of apre-compressed spring 2300 and/or movement of a actuation stick 2200.Thus, actuation guard 1200 can prevent accident activation of system1000 and/or unintended discharge of an actuating portion of the contents2500 of gas container 2400.

Once gas port 2600 has been punctured, an actuating portion ofcompressed gas 2500 can escape from container 2400 and flow via gasreservoirs 3000, such as gas channel 3100. The flowing gas can meetand/or apply gas pressure to medicament actuator 4000, which cancomprise a pusher 4100, which can travel within a sleeve 1500 defined bywalls 1520. Sleeve 1500 can be constructed of metal, stainless steel,aluminum, plastic, polycarbonate, etc. Seals 4200, such as o-rings, canresist gas leakage, such as past pusher 4100 and/or out of housing 1100.Thus, pusher 4100 can function as a piston traveling within a cylinder,although it is not necessarily required that the cross-sectional shapeof sleeve 1500 be round.

Medicament actuator 4000 can interface with medicament storage assembly5000. For example, medicament actuator 4000 can comprise a plurality ofplungers 4300, each of which can be capped with a piston 4400 which cansealingly slide and/or move within a corresponding vial 5100 containinga liquid medicament 5200. For example, in response to pressure appliedby an actuating portion of the contents 2500 of compressed gas container2400, pusher 4100 can cause plungers 4300 and/or pistons 4400 tosimultaneously move. The number of corresponding sets of plungers 4300,pistons 4400, and/or vials 5100 can be 2, 3, 4, 5, 6, or more. Pistons4400 can be constructed of a resilient, durable, and/or sealingmaterial, such as a rubber. Each plunger 4300 from the plurality ofplungers can define a longitudinal axis, the longitudinal axes (e.g.,axes 4310, 4320, 4330, 4340) of the plurality of plungers parallel,non-coaxial, and/or co-planar.

Each vial 5100 from the plurality of vials can be substantiallycylindrical with a substantially round and/or substantially ellipticalcross-sectional shape. Thus, each vial 5100 can define a longitudinalaxis, the longitudinal axes of the plurality of vials parallel,non-coaxial, and/or co-planar. The longitudinal axis of each vial can beco-axial with the longitudinal axis of its corresponding plunger.

Each vial can be capped at one end with a frangible 5300, which can beburst when piston 4400 generates sufficient pressure upon medicament5200, thereby allowing at least a portion of medicament 5200 to flow outof vial 5100 and into medicament carrier 9000. Thus, the plurality ofvials can be fluidly coupleable to the actuating portion of the contents2500 of gas container 2400.

Medicament carrier 9000 can hold each of vials 5100 and can travelwithin sleeve 1500. Medicament carrier 9000 can comprise a plurality ofchannels 9200 adapted to receive medicament 5200 as it exits itsrespective vial 5100, and direct medicament 5200 to a common conduit9300. Medicament carrier 9000 can interface with needle assembly 6000and/or use indicator 7000.

From common conduit 9300, medicament 5200 can enter needle assembly6000, such as into a single needle 6100 via which medicament canapproach needle tip 6200. As medicament actuator 4000 and/or medicamentcarrier 9000 are driven toward actuator bar 1300, needle tip 6200 canpenetrate an end 6400 of needle sheath 6300 and exit actuator bar 1300at needle port 1340.

Referring to FIG. 5, upon movement of actuation bar 1300 closer tohandheld portion 1800, sheath seat 1330 can come in contact with sheathtip 6400, thereby causing sheath 6300 to buckle and/or crumble. Asactuator bar 1300 comes in contact with handheld portion 1800, bar stop1320 can approach medicament carrier stop 9400, while carrier spring1600 is compressed.

Referring to FIG. 6, as at least a portion of contents 2500 of gascontainer 2400 escapes, it can flow through channel 3100. The gas, whichcan still be relatively pressurized, can begin to accumulate behindpusher 4100 to form an expanding gas chamber 3200 and to causemedicament actuator 4000, medicament storage assembly 5000, andmedicament carrier 9000 to slide together within sleeve 1500. Asmedicament actuator 4000, medicament storage assembly 5000, andmedicament carrier 9000 slide closer to actuator bar 1300, spring 1600becomes increasingly compressed between bar stop 1320 and medicamentcarrier stop 9400. As medicament actuator 4000, medicament storageassembly 5000, and medicament carrier 9000 slide closer to actuator bar1300, needle tip 6200 can extend further from actuator bar 1300 andsheath 6300 can become further compressed and/or deformed. At itsultimate extension point, needle tip 6200 can extend from housing 1100from approximately 0.25 millimeters to approximately 20 millimeters,including all values and subranges therebetween, such as up toapproximately 2 millimeters, greater than approximately 5 millimeters,from approximately 5.13 millimeters to approximately 9.98 millimeters,etc.

Referring to FIG. 7, as gas chamber 3200 continues to expand, medicamentcarrier 9000 can be driven until medicament carrier stop 9400 contactsactuator bar stop 1300 thereby resisting further travel of medicamentcarrier 9000. At that point, additional expansion of gas chamber 3200can cause medicament actuator 4000, pusher bar 4100, plungers 4300,and/or pistons 4400 to initiate travel with respect to medicamentstorage assembly 5000, thereby generating an expulsion pressure in vials5100, and/or thereby rupturing frangibles 5300 and allowing medicament5200 to enter medicament carrier 9000, and begin flowing throughmedicament channels 9200, medicament conduit 9300, needle 6100, and/orout needle tip 6200 and into a patient. Alternatively, frangibles 5300can be replaced and/or augmented by a frangible located at or near wheremedicament conduit 9300 couples to needle 6100. Frangibles 5300 can beconstructed of a thin, taught, resilient, durable, and/or sealingmaterial potentially having a predetermined yield strength, such as arubber, such as chromo butyl rubber, and/or of a relatively brittlematerial potentially having a predetermined yield strength, such asceramic, certain plastics, such as polystyrene, etc.

As medicament carrier stop 9400 contacts actuator bar stop 1300,medicament carrier hooks 9600 can engage with engagement receivers 7100in use indicator 7000.

Referring to FIG. 8, as gas chamber 3200 continues to expand, medicamentactuator 4000, pusher bar 4100, plungers 4300, and/or pistons 4400 cancontinue moving until they complete their travel within medicamentstorage assembly 5000, thereby expelling a predetermined dose ofmedicament 5200 from vials 5100, out of needle assembly 6000, externalto housing 1100, and/or into the patient. As gas chamber 3200 reachesits maximum size, medicament actuator 4000, pusher bar 4100, plungers4300, and/or pistons 4400 can continue moving until they complete theirtravel with respect to medicament carrier 9000, thereby causing gasrelease actuator 9700 to engage with gas release valve 8200. Engagementof gas release actuator 9700 with gas release valve 8200 can causewithin gas chamber 3200 to exit gas chamber 3200, discharge away frompistons 4400, and/or exhaust from system 1000 and/or housing 1100, suchas via status indicator 1400 and/or a gas escape port located on housing1100).

Referring to FIG. 8 and FIG. 9, as sufficient gas is vented from gaschamber 3200, the pressure applied by the gas in gas chamber 3200 candecrease until the force applied by the gas on medicament actuator 4000is less than the force of compressed spring 1600. Thus, spring(s) 1600can begin to expand, thereby moving medicament carrier 9000, vialassembly 5000, and medicament actuator 4000 away from actuator bar 1300and helping to exhaust gas from gas chamber 3200. As medicament carrier9000 moves, use indicator 7000 can travel with it, due to the engagedrelationship of medicament carrier hooks 9600 and engagement receivers7100 and/or engagement catches 7200 in use indicator 7000. As useindicator 7000 moves away from actuation bar 1300, sheath 6300 cantravel with it, thereby creating a gap between sheath tip 6400 andneedle port 1340, and thereby exposing a previously non-visible coloredportion 1350 of actuation bar 1300 and/or providing an indication thatsystem 1000 has been used (and likely substantially exhausted of itsmedicament), thereby discouraging any further attempts to use system1000.

As medicament carrier 9000 moves away from actuator bar 1300, needle6100 can retract into sheath 6300 which un-buckles and/or un-deformstowards its original shape. Eventually, needle 6100 can retractcompletely within the boundaries of housing 1100, thereby tending toprevent accidental needle sticks after the initial injection and/orpotentially reducing and/or eliminating a sharps hazard.

In certain exemplary embodiments, system actuator 2000 can comprise afinger triggered, twistable, pivotable, and/or lever-operated mechanism.For example, system actuator 2000 can comprise a twistable handle thatcan screw into gas port 2600. In certain exemplary embodiments, systemactuator 2000 can be a finger trigger located on a side of the housing.

FIG. 10 is a flowchart of an exemplary embodiment of a method 10000 foroperating a medicament delivery apparatus. At activity 10100, anactuation lock for the apparatus is released. At activity 10200, anactuating portion of the contents of a compressed gas container arereleased. At activity 10300, via pressure provided by the released gas,a needle is extended from the apparatus. At activity 10400, via pressureprovided by the released gas, a piston applies pressure to a medicamentstored in one of a plurality of vials. At activity 10500, a frangiblecontaining the medicament in the vial is burst. At activity 10600, themedicament flows from the vial, through the needle, and into a patient.At activity 10700, once a predetermined dose is expelled and/orinjected, the needle is withdrawn from the patient and/or retracted intothe pre-use bounds of the apparatus. At activity 10800, the apparatus isrendered unusable for additional injections and/or indicated aspreviously utilized.

FIG. 11 is a perspective view of an exemplary embodiment of system 1000,showing actuation guard 1200 removed from housing 1100, so thatactuation guard 1200 no longer separates actuator bar 1300 from handheldportion 1800. Actuation guard 1200 can comprise a grippable portion 1220that can be gripped by a user to pull actuation guard 1200 away fromhousing 1100, thereby allowing system 1000 to be activated, such as viaslapping actuator bar 1300 against a thigh of the user. Actuation guard1200 can comprise an actuation stick separator portion 1240, that cankeep separate actuation stick prongs 2240 when actuation guard 1200 isinstalled on housing 1100. Actuation guard 1200 can comprise a guardportion 1260 that can separate actuator bar 1300 from handheld portion1800 when system 1000 is not in use and/or when system 1000 has not beenused.

FIG. 12 is a perspective cross-sectional view taken along lines B-B ofFIG. 11, and FIG. 13 is a perspective view of an exemplary embodiment ofactuation stick 2200. Referring to FIGS. 12 and 13, system 1000 cancomprise housing 1100, actuation bar 1300, and system actuator 2000,which can comprise prong squeezer 1390, actuation stick 2200, prongretainer 2100, spring 2300, upper spring retainer 2260, gas container2400, gas port 2600, and/or puncturer 2700. When actuation bar 1300 ispressed firmly against a user's body, such as via slapping housingactuation bar against the user's thigh, buttocks, and/or arm, prongsqueezer 1390 can urge prong tips 2220 of prongs 2240 of actuation stick2200 toward one another. Note that prong tips 2200 can have atriangular, wedge, angular, and/or frustro-conical shape. As prongs tips2220 slide along the angled V-groove of prong squeezer 1390, prongcatches 2230 can substantially loose contact with prong retainer 2100.This can allow compressed spring 2300 to rapidly urge actuation stick2200 and gas container 2400 toward puncturer 2700, which can penetrategas port 2600, thereby allowing gas to escape from gas container 2400.Although any of many different types of gas containers can be utilized,an exemplary gas container can be obtained from Leland Limited, Inc. ofSouth Plainfield, N.J.

FIG. 14 is a cross-sectional view of an exemplary embodiment of gasventing mechanism 8000 of system 1000 taken along lines A-A of FIG. 3.System 1000 can comprise handheld portion 1800, actuator bar 1300,sleeve 1500. As pistons 4440 near the limit of their travels, medicament5200 can be expelled along medicament path 5900, which can extend pastfrangible 5300, through medicament channels 9200, medicament conduit9300, and needle 6100, and into the body of a user, such assubcutaneously, intramuscularly, and/or at a depth of from approximately0.25 millimeters to approximately 20 millimeters, including all valuesand subranges therebetween, such as up to 2 millimeters, greater than 5millimeters, etc.

As pistons 4440 near the limit of their travels, engagement of gasrelease actuator 9700 with gas release valve 8200 can cause compressedspring 8300 to move valve arm such that o-ring 8400 is urged away fromits seat 8500. This movement can reveal a passage 8600, via which gascan exit gas chamber 3200 along gas exhaust path 8900, which can extendbetween sleeve inner walls 1520 and outer walls 9100 of medicamentcarrier 9000. Eventually, gas exhaust path 8900 can extend betweenhandheld portion 1800 and actuator bar 1300. Likewise, an alternativeembodiment of valve 8200, made of rubber or any other resilientmaterial, can be placed across seat 8500 to provide a seal that, oncegas release actuator 9700 interacts with valve 8200, allows valve 8200to bend or flap upwards away from seat 8500, causing the gas to escapevia passage 8600.

The following paragraphs expands on the above and describe variousexemplary embodiments relating to compact auto-injectors that cancomprise and/or utilize a vial or a plurality of vials to store and/orcontain an injectable medicament. These auto-injectors can have acompact form factor, such as approximately the size of a credit card.There are many methods of delivering such medicaments in such compactdevices. The below descriptions cover multiple methods and/or mechanismsthat can effectively administer a medicament using a compactauto-injector.

Exemplary Embodiment One Methods of Utilizing an Auto-Injector

This exemplary embodiment describes a method of implementing anauto-injector utilizing a spring and/or gas driven system to administera medicament and/or comprises a needle protection system.

An embodiment for delivering medicament from a chamber can comprise avial or plurality of vials; said chamber in communication with a needlethat can be concealed initially by some shield and/or sheath; extendingsaid needle from the sheath at least 1 mm and/or inserting the needlepast a needle insertion point to an injection site at a depth of atleast 5 mm; the application of a force that can originate from thecontents of a gas cylinder and/or by means of a spring or multiplesprings sufficient to eject medicament held within said chamber into theneedle and/or through the needle insertion point to a depth of at least5 mm to deliver up to 5 ml of medicament into the injection site in lessthan 5 seconds; wherein the medicament can be injected and/or heldthrough the use of a vial system that comprises a plunger, vial(s),reservoir, and/or needle that can be located within said chamber;wherein the force can be applied on the plunger at the proximal endallowing for the plunger, vial(s), reservoir, and/or needle to traveltowards the distal end of the housing; wherein the plunger can slideablytravel through the vial towards the distal end to allow for theappropriate dose of medicament to be delivered; wherein the needleinsertion point can be located more superficial than the injection site;wherein the needle can have a length of at least 6 mm and/or themedicament can be ejected at a pressure of at least 25 p.s.i. at a rateof at least 0.20 ml/sec; and/or wherein the needle can retract into theshield and/or housing and/or a needle protection portion slides over theneedle following delivery of the medicament.

FIG. 15 shows an exemplary embodiment an auto-injector 15000. Though thefigure shows the force mechanism used as being a compressed gascontainer 2400, the force method can be created by a spring force (Seedescription of FIGS. 18A and 18B below). The top of the housing 1110 canbe laser-welded to ensure stability due to high pressure. Likewise, theentire housing 1130 can be a sealed housing, and may be made smaller byeliminating screws and/or pins holding the base 1310 and/or top 1110 tothe housing. In FIG. 15, this can be completed by adding hooks 1360 tothe base 1310. The hooks 1360 can allow the base 1310 to slide into thehousing 1130, thus pushing the detents 2225 inward and allowing for thepuncturing of the gas cylinder 2400 by activating the compressed spring2300. These hooks 1360 can also click into the housing 1130, making thebase 1310 unable to move post-injection; this eliminates re-use of thedevice and acts as an indicator to determine if the device has been usedor if the device has not been activated. The gas release mechanism isalso a novel addition to the device. A rubber flap 8210 (also referredto as a gas release flap) and/or other resilient material can be locatedinside the plunger bar 4350. A solid piece 9710 or member can stick upfrom the reservoir near the top of the vials. Once the plunger bar 4350dispenses the medicament, this piece 9710 can push the rubber flap up,thereby releasing excess gas in the system. The puncturing device forthe gas cylinder could be a roll-pin 2710 that is sliced at a 45 degreeangle to ensure sharpness for puncturing.

FIG. 16 shows the safety tab 1210 used to protect the user fromaccidental activation. FIG. 16 also shows an extended portion 1215 ofthe safety tab 1210 with grooves 1218 added to it. This can aid the userin removing the safety tab 1210 by creating a larger gripping surfaceand/or a more tactile feel to the tab.

Exemplary Embodiment Two Chemical Reaction

This exemplary embodiment involves an auto-injection system thatutilizes a chemical reaction as an activation mechanism to deliver themedicament into a patient. It also comprises a needle protection system.

This exemplary embodiment comprises a delivery system that can encompassa housing, vial or plurality of vials, plunger for each vial, singleneedle or needle cannula, and medicament or medicaments within the vialor plurality of vials; the vial or plurality of vials in communicationwith the plunger(s) at proximal end and in communication with areservoir that contains a single needle or needle cannula at the distalend; the needle can be protected by some sheath/shield; a chemicalreaction capable of occurring when one chemical is allowed to interactwith another chemical and/or a substance that may create such a reactionthrough the use of some activation mechanism; and said chemical reactionthat can generate a force that is strong enough to drive said plunger,vial, reservoir, and needle towards the distal end of the housing; theneedle exiting said sheath/shield and entering an injection site; theplunger(s) slideable in the vial(s) that contain the medicament; andsaid medicament exiting the vials into through the reservoir and needlecannula into the injection site; upon exit of the desired contents ofthe vial, the entire needle, reservoir, vial, and plunger assembly canretract towards the proximal end of housing by some means such as awire, spring, o-ring, and/or rubber membrane and/or a needle protectionportion slides over the needle following delivery of the medicament.

FIG. 17 is a view of the compact injector 17000 with severalmodifications to allow for a chemical reaction to occur as the primaryforce method in order to deliver the medication. In the particulardrawing, the puncturing pin 2712 can include a rough surface 2714.Likewise, the container 2401 used in the device can have a similar roughmaterial and/or surface 2402, and can contain mostly Sodium Azide(NaN3). Once the spring 2300 (attached to the container) is activated,the two rough surfaces 2714, 2402 can simultaneously come in contactwith each other to create a spark and puncture the Azide container. Thiscan create an immediate chemical reaction because of the spark. Thereaction (2 NaN3−>2 Na+3 N2) can form hot nitrogen gas and sodium inorder to create enough force to inject the medication. A modification tothis figure can be made to include another container at the top in placeof the puncturing pin that can break open from the force of the springand second container, thus mixing the two chemicals and can cause achemical reaction to occur in order to produce the force needed.

Exemplary Embodiment Three The Spring Driven Injector

Certain exemplary embodiments of the auto-injector can use a spring ormultiple springs to inject the medicament into a patient. The novelty ofthis system can lie in the orientation of the activation springs and thevial system (that comprises the plunger, vial(s), reservoir and theneedle/cannula) system. Because the activation springs can be located inparallel to the vial system, the device can be smaller than existingdevices on the market (that are linear in nature), potentially having aform factor that is approximately the size of a credit card.

Certain exemplary embodiments can comprise a delivery system that canencompass a housing, vial or plurality of vials, plunger for each vial,single needle or needle cannula, and medicament and/or medicamentswithin the vial or plurality of vials; the vial or plurality of vials incommunication with the plunger(s) at proximal end and in communicationwith a reservoir that contains a single needle or needle cannula at thedistal end; the needle protected by some sheath/shield; the housingfurther comprising at least one spring (this can comprise a gas spring,coil spring, leaf spring, etc.) wherein the spring(s) is parallel to theplunger, vial(s), and reservoir system and is in communication with asolid member (that can be made of rubber, plastic, metal, and/or someother resilient material) that is also in communication with theproximal end of the plunger such that when the spring(s) is activated, aforce is applied on the plunger at the proximal end allowing for theplunger(s), vial(s), reservoir, and needle to travel towards the distalend of the housing; wherein the plunger can slideably travel through thevial towards the distal end to allow for the appropriate dose ofmedicament to be delivered; the solid member is displaced away from theplunger, which can allow for the retraction of the entire needle,reservoir, vial(s), and plunger assembly towards proximal end of housingby some means such as a wire, spring, o-ring, and/or rubber membraneand/or for a needle protection portion to slide over the needlefollowing delivery of the medicament.

FIGS. 18A and 18B shows several views of the spring driven injector18000. The primary force used to push down the pusher bar 4360, vialsystem 5110, reservoir 9210, and needle 6100 can be provided bycompressed springs 2410. In the cross-section drawing (FIG. 18B), twosprings 2410 can be located on the outside of the central chamber(containing the pusher bar 4360, vials 5110, reservoir 9210, and needle6100). The springs 2410 can be held in place by a rod 2412 coupled withhooks 2414. Each spring 2410 can have a rolling solid member 2420attached to it that is also connected to a bar 2422 that is held into anotch/indentation in the reservoir 9210 near the bottom of the vials5110. Furthermore, a solid beam 4365 can wrap around the top of thepusher bar 4360 and can attach to the aforementioned bar 2422. The bar2422 can slide in and out of the reservoir 9210 and the solid beam 4365,but only if the rolling solid member 2420 is rolled away from thereservoir 9210 and beam 4365. The device can be activated by the userpulling out the safety mechanism 1211 and pushing downward on theoutside sleeve 1112. This can cause the hooks 2414 from the rods holdingthe springs 2410 in place to pinch inward, thereby releasing the springs2410 forcefully downward. As the springs 2410 are driven downward, therolling solid member 2420 and bar 2422 can roll down through the solidmember passage 2430, which detours out of and away from the reservoir9210. As the rolling solid member 2420 is moved, the solid beam 4365wrapped around the pusher bar 4360 can come down as well, pushing theneedle 6100 into the user. The medication can then be delivered into theuser and/or patient once the rolling solid member 2420 goes down evenfurther, which can be continually driven by the force of the springs2410. The solid member 2420 passage eventually can turn away from thevial system 5100 and reservoir 9210 (also shown in the side view drawingas a hidden line). This can slide the bar 2422 out of the reservoir 9210and out of the beam 4365, allowing for the retracting springs 1610 topush the pusher bar 4360, vials 5100, reservoir 9210, and needle 6100back into the housing.

Exemplary Embodiment Four Pulley System

This exemplary embodiment can utilize a pulley system as the activationmechanism for injecting medicament into the patient and that can alsocomprise a needle protection system.

Certain exemplary embodiments can comprise a delivery system that canencompass a housing, vial or plurality of vials, plunger for each vial,single needle or needle cannula, and medicament or medicaments withinthe vial or plurality of vials; the vial or plurality of vials incommunication with the plunger(s) at proximal end and in communicationwith a reservoir that can contain a single needle or needle cannula atthe distal end; the needle that can be protected by some sheath/shield;the housing further comprising one or more spring pulley system(s) thatcan constitute a spring connected to some slideable resilient materialsuch as a string, wire, wire coil, flat metallic band, etc. at theproximal end of the housing, and said material that can travel through achannel in the housing from the proximal end of the housing towards thedistal end of the housing and then returning through a parallel channeltowards the proximal end wherein this material is connected to a solidmember (made of rubber, plastic, metal, and/or some other resilientmaterial); the solid member in communication with the proximal end ofthe plunger such that when the spring is activated the spring canproduce enough force to allow the pulley system to operate by having theresilient material, such as a cord, which can forcefully travel towardsthe proximal end of the housing and can cause the cord to move the solidmember in communication with the plunger, vial(s), reservoir, and/orneedle towards the distal end; wherein the needle can exit saidsheath/shield and can enter an injection site; the plunger(s) slideablein the vial(s) that can contain the medicament; and said medicament canexit the vials into through the reservoir and/or needle cannula into theinjection site; upon exit of the desired contents of the vial, the solidmember can be displaced away from the plunger allowing for the entireneedle, reservoir, vial(s), and/or plunger assembly to retract towardsthe proximal end of housing by some means such as a wire, spring,o-ring, and/or rubber membrane and/or a needle protection portion toslide over the needle following delivery of the medicament.

A pulley system 2435 is shown in the device 19000 depicted in FIG. 19 asthe primary method for forcing the pusher bar 4360′, vials 5110′,reservoir 9210′, and needle 6100 down for medicament injection. Similarto the above spring-driven injector 18000, the activation springs 2410′can be located parallel to the vial system 5110′ and the device can beactivated by the user pushing down on the outside sleeve 1112′ of thedevice. The use of a pulley system 2435 can create a mechanicaladvantage, producing the proper force needed to efficiently push downthe vial system 5100′ and deliver the proper dose of medication. FIG. 19shows a bar 2422′ that can be connected to the end of the rod/springmember. This bar 2422′ can be connected to the pulley system 2435 (thatcan comprise some resilient and/or moveable material). The other end ofthe pulley system 2435 can be connected on top of the pusher bar 4360′to a beam 4366 that can be able to slide when moved to a certainposition. As the springs 2410′ are driven downward, the pulley system2435 can pull the pusher bar 4360′, vials 5100′, reservoir 9210′, andneedle 6100 down as well. Similar to the spring-driven injector, thesolid beam member 4366 on top of the pusher bar 4360′ can slide down thesolid member passage 2430′ and eventually dislodge from the pusher bar4360′. Once this occurs, the entire system can retract back within thehousing due to the force from the retracting springs 1610′.

Exemplary Embodiment Five The Needleless Injector

This exemplary embodiment can comprise a Needleless Injector that can begas and/or spring activated and that can allow for a user to inject amedicament into a patient without the use of a needle. The use of aplurality of vials can be considered the novel component and can allowthe device to be compact in nature, such as having the approximatelength and width similar to that of a credit card.

Certain exemplary embodiments for delivering medicament from a chambercan comprise a plurality of vials; the said chamber in communicationwith a passage into a small injection opening; the application of aforce that can originate from the contents of a gas cylinder and/or bymeans of at least one spring that can eject medicament held within saidchamber into the passage to the small injection opening, which can bedefined and/or created by the housing and/or a small sterile rod thatcan be a needle or cannula allowing for the slight puncturing of theinjection site in order to allow the medicament to be delivered, andthrough the tip of this small injection opening to a depth of at least 1mm, that can deliver up to 5 ml of medicament into the injection site;wherein the medicament can be injected and held through the use of avial system that comprises a plunger, vial(s), and/or reservoir alllocated within said chamber; wherein the force can be applied on theplunger at the proximal end allowing for the plunger, vial(s), and/orreservoir to travel towards the distal end of the housing; wherein theplunger can slideably travel through the vial towards the distal end toallow for the appropriate dose of medicament to be delivered through thereservoir into the small injection opening; wherein the injectionopening point can be located more superficial than the injection site;wherein the medicament can be ejected at a pressure of at least 25p.s.i. (For example, in such embodiments, the pressure to deliver a doseof 0.5 cc's could be about 100 pounds of force).

FIG. 20 depicts the components of the needleless injector 20000. Theinjector can be activated by removing a safety tab 1212 and pushing downon the housing 1131. The rod 2412 with hooks holding the spring 2410 inplace can be initiated by the base 1312 moving upwards and pushing thehooks inward. The spring 2410 can drive the high pressure gas cylinder2400 into a puncturing pin 2716, releasing the gas cylinder contents.The gas cylinder contents can push down the pusher bar 4361, vials 5100,and reservoir 9212 into the small opening 6114 at the base of the devicenear the injection site. The small opening 6114 allows passage of amedicament or agent and also a slight puncturing of the injection site.A tiny cannula 6110 and/or needle can be located at the bottom of thereservoir 9212 and/or can be used for slightly puncturing the injectionsite. The cannula defines a tiny orifice 6112 therein for passage of themedicament or agent. This slight puncture can allow the medicamentstored in the vial 5100 to flow through the reservoir 9212 and into theinjection site. Once the pressure is released, the entire system(including the pusher bar, vials, and reservoir) can be pushed back upwithin the housing by the retracting springs 1610.

Exemplary Embodiment Six The Multi-Pharmaceutical Injector

This exemplary embodiment can comprise a compact auto-injector that canincorporate a plurality of vials, allowing for multiple medicaments tobe injected at one time or at different times. The use of a plurality ofvials can be considered the novel component and also can have theadvantage of creating a device that is compact in nature, such as onehaving the length and width of a credit card. The device also cancomprise a needle protection system.

Certain exemplary embodiments for delivering medicament from a chambercan comprise a plurality of vials; the said chamber or chambers incommunication with a needle or needles that can be concealed initiallyby shields and/or sheaths; that can extend said needle from the saidsheath at least 1 mm and can insert the needle past a needle insertionpoint to an injection site at a depth of at least 5 mm; the applicationof a force and/or forces that can originate from the contents of a gascylinder and/or multiple gas cylinders, and/or by means of a springand/or springs sufficient to eject medicament held within said chamberinto the needle and through the needle insertion point; wherein themedicament can be injected and held through the use of a vial systemand/or vial systems that can comprise a plunger, vial, reservoir, and/orneedle all located within said chamber(s); wherein the force can beapplied on the plunger at the proximal end allowing for the plunger,vial, reservoir, and/or needle to travel towards the distal end of thehousing; wherein the plunger can slideably travel through the vialtowards the distal end to allow for the appropriate dose of medicamentto be delivered; wherein the needle insertion point can be located moresuperficial than the injection site. The device potentially having amultitude of said components (including but not limited to vials,plungers, gas cylinders, springs, needles, reservoirs, sheaths, shields,chambers, and/or retracting springs) in order to administer multiplemedicaments into a patient at one time and/or at different times, as onedose and/or in multiple doses, depending on when each individual systemis activated. The device can have selectors and/or other mechanisms toallow the user to choose which medicament to administer. Each individualsystem can comprise an activation mechanism (such as a spring and/or gascylinder), a chamber within said housing, and a plunger, vial,reservoir, needle, and/or retraction spring; wherein upon exit of thedesired contents of the vial, the entire needle, reservoir, vial, and/orplunger assembly retracts towards the proximal end of housing by somemeans such as a wire, spring, o-ring, and/or rubber membrane and/or aneedle protection portion slides over the needle following delivery ofthe medicament.

A method for administering multiple pharmaceuticals is depicted in FIGS.21A and 21B. The injector 21000 can include medicament selectors 5500 inorder to allow the user to select which medicament to inject. The usercan select the medicaments by sliding one or more selectors 5500 upwardinto their final position. An audible click or some other indicator mayoccur to alert the user to this final position. Moving the selector ormultiple selectors upwards can allow a pin 5510 to snap into the plungerrod 5512 and/or into the pusher bar, which can create an entire portionthat can push the vial system downwards and can inject the medicationthrough the vial, the reservoir and/or needle. (This method can also beused with the Needleless injector method as described earlier in thisdocument) Methods such as this embodiment could be extremely useful inapplications for anti-nerve agents or pain therapies. The device 21000can also include a resilient material, such as rubber, to seal theselector openings and that can also slide within the housing once theselector 5500 is pushed upward. Once the aforementioned pins 5510 are inplace, the device can function and activate similarly to that describedabove. A safety mechanism can be modified to eliminate the slidingselectors from being prematurely pushed upwards.

Exemplary Embodiment Seven The Wet/Dry Injector

This exemplary embodiment can comprise a compact auto-injector that canhave the ability to mix two or more medicaments in either a liquid orpowder form to create one injectable medicament. The novel component ofthis device can be considered to be the use of a plurality of vials todeliver the medicament. The device also can comprise a needle protectionsystem.

An exemplary delivery system can comprise a housing, plurality of vials,plunger for each vial, a mixing activation mechanism, an activationchamber or vial, single needle or needle cannula, and/or a medicament ormedicaments stored within each vial. Pre-injection, two or moremedicaments can be stored separately in a vial and/or storagecompartment and can communicate with each other once the mixingactivation mechanism is initialized. The mixing activation mechanismcould comprise a button, trigger, threaded rod, and or some other memberthat removes a piece or portion and/or punctures a piece or portion thatis preventing each medicament to communicate with each other. The mixingactivation mechanism may comprise a membrane, piece, and/or portion thatmay be removed pre-injection by the user in order to allow the separatevials and/or storage containers to communicate with each other. Themixing activation mechanism can be a piece that is manipulated in someway by the user in order to cause the contents of each compartment tomix with each other. This communication may occur by shaking the deviceand/or may occur automatically with the mixing activation mechanism. Forinstance, the mixing activation mechanism may cause each medicament tobe released into an activation chamber, which may itself be a separatevial. This mixed medicament can be the medicament that will be injectedinto the patient. The delivery system further encompassing the mixedmedicament vial or plurality of mixed medicament vials in communicationwith the plunger(s) at the proximal end of the housing and incommunication with a reservoir that can contain a single needle orneedle cannula at the distal end; the needle can be protected by somesheath/shield; the housing can further comprise a passage that is alsoin communication with the proximal end of the plunger such that when thespring(s) is activated from the distal or proximal end, a force can beapplied through the passage on the plunger at the proximal end allowingfor the plunger(s), vial(s), reservoir, and/or needle to travel towardsthe distal end of the housing; wherein the force provided can be causedby a spring, bar, contents from a gas cylinder, and/or other forcemechanism; wherein the plunger can slideably travel through the vialtowards the distal end to allow for the appropriate dose of medicamentto be delivered; upon exit of the desired contents of the vial, theentire needle, reservoir, vial, and/or plunger assembly can retracttowards the proximal end of housing by some means such as a wire,spring, o-ring, and/or rubber membrane and/or a needle protectionportion slides over the needle following delivery of the medicament.

FIGS. 22A and 22B depict a novel method for injecting lyophilizedmedications, and/or powdered biologics that could need to bereconstituted pre-injection. FIG. 22A shows a mechanism to mix and/orcreate an injectable medicament from two or more separate aforementionedsubstances. The figure depicts multiple vials 5110 that could have twosubstances in each vial separated by a pierceable membrane 5112 and/orother frangible piece. The vials in this embodiment can have one wetsubstance 5210 (such as sterilized water) and one dry substance 5220(such as glucagon powder). The user can take off the safety tab 1230,which can prevent the user from accidental injection and/or pre-matureactivation of the device. Once the safety device 1230 is removed, theuser can twist and/or rotate the twisting portion 5150 at the top of thehousing. By rotating this top portion, the rods 5152 attached to thisportion (which can be threaded rods) can move downward. These rods 5152can be located in the vials 5110 and/or through the pusher bar 4362. Therods 5152 can have a sharp piercing portion on the distal end which canaid in puncturing the aforementioned pierceable membrane 5112 that canseparate the substances in the vial. Once the piercing rod 5152punctures the frangible and/or pierceable membrane, the substances canmix together to form one medicament. The user can also shake the entirehousing in order to aid in this mixing process.

Exemplary Embodiment Eight Needle-End Safety System

Certain exemplary embodiments can comprise a safety system that canallow a user to remove some cap, bar, lock at the same end of anauto-injector housing where the needle is located. This can allow thedevice to be ready for activation while still protecting the needle atthe same time. Many auto-injectors, such as most pen-like injectors,have the activation safety mechanism on the opposite end of where theneedle is located. In an emergency situation, the user may mistake thissafety cap as protecting the needle, when in fact this is not the case.There have been many documented cases of digital injection into a user'sthumb or finger because of this reason. Having the safety mechanism atthe same end of the needle can eliminate this risk.

Exemplary Embodiment Nine Auto-Injector with Feedback

The use of auto-injectors and drug delivery systems is common in themedical industry. Auto-injectors can deliver a range of medicaments intoa patient, ranging from chronic therapies to critical care injectables.As more therapies are developed, the need for a vehicle to deliver thesetherapies is ever-increasing. Certain auto-injectors currently on themarket can lack attributes that can allow the user to understand thedevice's functionality and/or operation. Thus, there is perceived a needfor an auto-injector that can provide audible, haptic, and/or visualfeedback to the user in order to effectively train and/or guide the useron how to properly operate the auto-injector and/or to mitigateuser-related hazards that could occur when the device is not usedcorrectly.

The incidence of use-related hazards associated with auto-injectors isincreasing. Common problems associated with certain injectors on themarket include poor design, sharps exposure, and poor instruction. Manyauto-injectors on the market are in the form of an apparatus thatresembles a pen or marker. The safety mechanism for most of thesedevices can cause patient confusion as it is often protecting theactivation mechanism and not the location where the needle protrudes outof the device. There have been numerous cases of the user accidentallyinjecting the needle into their own thumb or finger because of thishazard. Examples of devices that incorporate this design can includecertain pen-type auto-injectors for allergic emergencies, and/or certainanti-nerve agent auto-injectors currently supplied to both domestic andforeign militaries. These devices, and most auto-injectors on themarket, also can allow the needle to remain protruding out after use,thereby potentially causing a post-injection sharps hazard. Further,many of these injectors exhibit poor instruction and/or labeling. Due tothe cylindrical design of certain auto-injectors, the surface area forlabeling can be small, rounded, and therefore can prevent a user fromeasily reading important information regarding the use of the device.For many injectors that are used in emergency situations, it can beimportant that the user be able to use the device correctly andefficiently. The user might not take or have time to read theinstructions on the device during such a critical scenario.

For one or more of these reasons, an interactive auto-injector ormedical device is described that can provide a user with visual, haptic,and/or audible feedback in order to mitigate the aforementioned risksand/or to allow for easy injection of medications.

Certain exemplary embodiments can provide an interactive auto-injectorand/or a method of providing audible, haptic, and/or visual feedback toa user when operating the auto-injector. An auto-injector can be definedas any device that allows a user to deliver a medicament without havingto manually prepare the injection. This can include pen deliveredinjectors, syringes, needleless injectors, gas powered auto-injectors,and/or any other auto-injector and/or medical device used to inject apharmaceutical into a user/patient, etc.

Certain exemplary embodiments can provide an auto-injector that cancomprise an information device and/or system comprising at least onesensor (e.g., a pressure sensor, proximity sensor, tactile sensor,and/or biometric input device, etc.), switch (e.g., gate switch,microswitch, and/or pushbutton, etc.), embedded system (e.g.,microprocessor, memory, embedded operating system, system bus,input/output interface, and/or network interface, etc.), audible outputsub-system (e.g., speaker, horn, buzzer, and/or piezoelectrictransducer, etc.), visual output sub-system (e.g., flag, marker, light,liquid crystal display (LCD), light emitting diode (LED), optical fiber,organic polymer display, electric paper, screen, display, monitor,and/or tube, etc.), haptic output sub-system (e.g., buzzer, vibrator,bulging portion, tactile stimulator, cooler, and/or heater, etc.),and/or any other component and/or sub-system that would aid in providingaudible, visual, and/or haptic feedback to a user of the auto-injector,along with appropriate circuitry, control system(s), housing(s),shielding, electrical conductors, and/or power source(s), etc.

Certain embodiments of auto-injectors can comprise a housing, safetymechanism, activation mechanism (such as a spring means or compressedgas cylinder), a vial or container for storing the medicament, and aneedle for delivering the medicament. Certain exemplary embodiments canprovide one or more audible, visual, and/or haptic outputs to guideand/or instruct the user how to use the auto-injector properly. Sensorsand/or switches can be placed on the safety tab, on the bottom of thedevice where the needle comes out, and/or where the inner sleeve slidesup to activate the device. Visual outputs can be placed at each of theaforementioned locations as well and/or instead. An audible outputsub-system can be placed anywhere on the device for audible feedback. Ahaptic output sub-system can be placed anywhere on the device. Theseelectronically-triggered and/or active components and/or sub-systems canbe incorporated into the labeling of the device and/or as a separatecomponent to provide this visual, haptic, and/or audible feedback.

For example, the user can push a button or switch on the device toinitiate the audible, haptic, and/or visual output sub-system. Apre-recorded audible voice can tell the user to pull up on the safetytab, while a visual and/or haptic output can be rendered on the safetytab to provide a visual and/or haptic clue to the user as to where thesafety tab is located. Once the safety tab is pulled up correctly, asensor or switch could trigger the next step for the voice to announce,for example, asking the user to place the base of the device on theouter portion of their thigh while also triggering a visual output tolight the base of the device. By way of further example, the user can beprovided a visual clue in which at least a portion of the base of thedevice is lighted and/or colored red, and/or the user can be provided ahaptic clue in which the base on the device is moved and/or the base isheated sufficiently (such as to between approximately 105 degrees F. andapproximately 120 degrees F., including all values and subrangestherebetween) to substantially warm, yet not burn, the user's skin. Theembedded operating system, which can run in hard real-time to avoiddelays that might be significant and/or life-threatening, can alsorecognize a failure to complete a step in a certain specific timeframeand cause the step to be repeated if necessary and/or provide negativefeedback if the user fails to perform a step properly (e.g., via inputfrom a sensor or switch, the operating system can timely notice that thedevice is not placed on the skin of the thigh correctly and can causethe audible output subsystem to tell the user to repeat the placementstep). Once the user places the device on the thigh properly, the sensoror switch could trigger the next audible, visual, and/or haptic clueand/or output, such as asking the user to push down on the outsidesleeve of the device with force. By instructing the user step-by-stepthrough each task, user error and/or risks of certain hazards can bereduced and/or eliminated.

Certain exemplary embodiments can provide a compact, credit card-sizedauto-injector used to deliver a variety of medicaments, such aspharmaceuticals and/or agents. Though this auto-injector can eliminatemany problems associated with certain pen-style auto-injectors, such asthe sharps hazard and/or the poor safety tab design, there can be a needfor an interactive auto-injector in order to aid in user instruction ofthe device and/or to help ensure the device is used properly any and/orevery time it is needed. The following, and the attached figures,further describes such an auto-injector.

FIG. 23 portrays an auto-injector 23000 having a housing 1131 similar tothe length and width of a credit card, an activation mechanism on oneside and a vial system 5100 non-coaxial with the activation mechanism.The activation mechanism can comprise a compressed spring 2410 andcompressed gas cylinder 2400 used as the force mechanism, and apuncturing mechanism 2718 to dispel the contents of the compressed gascylinder 2400. A vial system 5100 can be comprised of a pusher bar 4363,plungers, vial(s)/medicament storage container(s), a reservoir 9214, aneedle 6100, and a needle sheath. Retraction springs 1610 located at thebase of the reservoir 9214 can push the needle 6100 back within thehousing 1131 after injection. A slideable base 1314 can be used toactivate the activation mechanism, which can be transparent to show thelocation of the aforementioned needle. A safety tab 1232 can be locatedbetween the base 1314 and the housing 1131 and/or can keep theactivation mechanism from being activated while protecting the user fromthe needle 6100. Sensors 9810A, 9810B and/or switches, which can helptrigger audible, haptic, and/or visual feedback, can be located on thebase 1314 and/or on the safety tab 1232. A button 9805 and/or switch,which can help trigger audible, haptic, and/or visual feedbacksubsystem(s), can be located on the housing 1131. The feedbacksub-system(s) can be activated based on inputs received and/orinterpreted by the embedded operating system.

For example, an audible output sub-system 9820 located in the housing1131 can provide audible feedback to the user of the device. The audibleoutput sub-system 9820 can be comprised of one or more piezoelectrictransducers, small and/or large cones and/or speakers, sensors,capacitors, memories, power sources (e.g., battery, fuel cell,spring-actuated generator, etc.) housing, wires, and any otherelectronic components needed to provide recorded audible feedback to auser. The audible output sub-system 9820 can be activated by theaforementioned button 9805 or switch on the housing 1131. The speakercan provide instructions for how the device is used and/or certainmedication requirements.

As another example, visual outputs can be located throughout the device,and/or on the base, safety tab, labeling, and/or housing to providevisual clues to the user. These visual outputs can be activated by theoperating system once a sensor or switch is triggered. An LCD, opticalpolymer, LED, electric paper, and/or other form of display, monitor,and/or screen and/or other visual output can provide data to the usersuch as dosage amount, expiration date, instructions, Federal DrugAdministration (FDA) requirements, and/or other labeling requirements,etc.

Referring to FIGS. 24 and 25, the user can push the button on thehousing to, via the embedded processor, activate the audible, haptic,and/or visual feedback sub-system on the auto-injector. For example, avoice from the audible output sub-system (now activated) can provide anaudible message to the user, such as “Please remove the safety tab.” Thesafety tab 1232′ can also light up from visual outputs 9822A located onthe safety tab 1232′. Once the safety tab is removed, a sensor 9810C canbe triggered that can also trigger the next audible task from theaudible output sub-system 9820. The visual outputs (e.g. LEDs) 9822A andsensors (e.g., 9810C) activate the audible instructions for using thedevice, and to indicate key components of the device. If the safety tab1232′ is not removed within a certain timeframe, the first voiceresponse can be repeated. The button or switch can be pressed severaltimes or held in order to stop the process (in case the injector doesnot need to be used or the button was pressed accidentally). After thesafety tab 1232′ is removed, the next audible clue can be annunciated,such as “Please place the base of the device on the outer portion ofyour thigh.” The base 1314′ can simultaneously light up during thisaudible clue, providing a visual clue that demonstrates where the baseis located and/or what portion of the base should be placed on thethigh. A sensor or switch, located on the base 1314′, can be used tohelp determine if the auto-injector is placed correctly on the injectionsite. The same switch and/or sensor, and/or another switch and/or sensorlocated on the base 1314′ can help trigger the next audible message,such as “Push down on the top of the device to activate the injector.”That switch and/or sensor can also trigger one or more visual outputs9822B to light up the labeling 9830 and/or an arrow pointing down towardthe injection site (as shown in FIG. 24). The visual outputs (LEDs)9822B with the label 9830 highlight placement of the injector and properactivation.

Certain exemplary embodiments can comprise a compact auto-injector thatcan have the ability to mix two or more medicaments, agents, solutes,solvents, etc., in either a liquid or powder form and/or create oneinjectable medicament. Certain exemplary embodiments can include aninteractive system that can provide haptic, audible, and/or visualfeedback to provide the user with instructions, hints, and/or clues inorder to use the device properly. The auto-injector also can comprise aneedle protection system.

An exemplary delivery system can comprise a housing, plurality of vials,plunger for each vial, a mixing activation mechanism, an activationchamber or vial, single needle or needle cannula, and/or a medicament ormedicaments stored within each vial, etc. Prior to injection, two ormore medicaments can be stored separately in a vial and/or storagecompartment and can fluidically communicate with each other once themixing activation mechanism is initialized. The mixing activationmechanism can comprise a button, trigger, threaded rod, and or someother member that removes a piece or portion and/or punctures a piece orportion that is preventing each medicament from communicating with eachother. The mixing activation mechanism can comprise a membrane, piece,and/or portion that can be removed pre-injection by the user in order toallow the separate vials and/or storage containers to fluidicallycommunicate with each other. The mixing activation mechanism can be apiece that is manipulated in some way by the user in order to cause thecontents of each compartment to mix with each other. This communicationcan occur by shaking the device and/or can occur automatically with themixing activation mechanism. For instance, the mixing activationmechanism can cause each medicament to be released into an activationchamber, which may itself can be a separate vial. This mixed medicamentcan be the medicament that will be injected into the patient.

The delivery system can comprise the mixed medicament vial or pluralityof mixed medicament vials in mechanical and/or fluid communication withthe plunger(s) at the proximal end of the housing and in mechanicaland/or fluid communication with a reservoir that can contain a singleneedle or needle cannula at the distal end. The needle can be protectedby a sheath and/or shield. The housing can comprise a passage that isalso in mechanical and/or fluid communication with the proximal end ofthe plunger such that when the spring(s) is activated from the distal orproximal end, a force can be applied through the passage on the plungerat the proximal end allowing for the plunger(s), vial(s), reservoir,and/or needle to travel towards the distal end of the housing. Theapplied force can be caused by a spring, bar, contents from a gascylinder, and/or other force mechanism. The plunger can slideably travelthrough the vial towards the distal end to allow for the appropriatedose of medicament to be delivered. Upon exit of the desired contents ofthe vial, the entire needle, reservoir, vial, and/or plunger assemblycan retract towards the proximal end of housing by some means such as awire, spring, o-ring, and/or rubber membrane and/or a needle protectionportion slides over the needle following delivery of the medicament.

The interactive system can comprise a speaker sub-system that cancomprise piezos and/or other components to produce audible sounds and/orhuman voice; a haptic sub-system that can provide haptic feedback to theuser; a visual sub-system that can comprise light emitting diodes,LCD's, optical fibers, and/or other components that can produce visualoutputs such as light and/or color; a processor that can be used tocontrol the activation of such components; a power source such as abattery that can power the aforementioned interactive system; and/orswitches, buttons, and/or sensors that can activate certain visual,haptic, and/or audible clues at a particular moment.

FIG. 25 depicts a novel method and device 25000 for injectinglyophilized medications, and/or powdered biologics that might need to bereconstituted pre-injection. FIG. 25 shows a mechanism to mix and/orcreate an injectable medicament from two or more separate aforementionedsubstances. FIG. 25 depicts multiple vials 5110 that can have, forexample, at least two substances in each vial separated by one or morepierceable membranes and/or other frangible pieces. The vials 5110 canhave at least one wet substance 5210 (such as sterilized water) and atleast one dry substance 5220 (such as glucagon powder). The user cantake off the safety tab, which can prevent the user from accidentalinjection and/or pre-mature activation of the device. Once the safetytab and/or device is removed, the user can twist and/or rotate thetwisting portion 5150′ at the top of the housing. By rotating this topportion, the rods 5152′ attached to this portion (which can be threadedrods) can move downward. These rods 5152′ can be located in the vials5110 and/or through the pusher bar 4364. The rods 5152′ can have a sharppiercing portion on the distal end which can aid in puncturing theaforementioned pierceable membrane(s) that can separate the substancesin the vial 5110. Once the piercing rod punctures the frangible and/orpierceable membrane(s), the substances previously separated thereby canmix together to form one medicament. The user can also shake the entirehousing 1132 in order to aid in this mixing process. The device 25000includes an activation mechanism 2416, and delivers mixed medicamentfrom the vials 5110 through the reservoir 9215 and to the needle 6100.

The device 25000 can include an electronic/interactive system to providevisual, haptic, and/or audible feedback to the user. This interactivesystem can include a microprocessor 9807 to control the specificfeedback components, a speaker subsystem 9820, a haptic sub-system, asub-system of switches and/or sensors (see switches and/or sensors9810D, 9810E, 9810F), a subsystem of LEDs or optics, a battery powersource 9808, and any other component needed to produce audible or visualoutputs. FIG. 25 portrays these components located throughout thedevice; however, the actual placement of these components is flexible.The user can activate the interactive system by pushing a button 9804 orswitch located on the housing 1132 of the device. This button 9804 orswitch can activate the processor 9807 which can then send signals tothe audible output sub-system, haptic output sub-system, and/or visualoutput sub-system. The audible output sub-system 9820 can provide anaudible clue for the initial task, which can be in the form of a human,humanesque, and/or understandable voice stating, “Please remove thesafety tab.” A signal can also be sent simultaneously to the safety tabvisual output (potentially one or more LEDs) to provide a visual lightand/or color clue to the user as to where the safety tab is located.Once the safety tab is removed, a switch or sensor 9810E can send asignal to the processor 9807 and activate the next audible, haptic,and/or visual clue. This can be a human voice that states “Please twistthe top portion of the injector to activate the mixing mechanism.” Aswith the safety tab, an LED or some other visual clue then can beactivated, lighting up the mixing activation mechanism 5150′, and/or ahaptic clue can be activated, such as vibrating, warming, cooling,bulging, moving, changing a texture of, etc., the mixing activationmechanism 5150′. A switch or sensor 9810D located near or on the mixingactivation mechanism 5150′ can be used to ensure that the mixing wascomplete and to trigger the next audible and/or visual clue by theprocessor. A voice next can state, “Please shake gently to mix thesolution.” After a certain amount of time, the processor 9807 then cansend a signal to the audible output sub-system for the next task. Thiscan be a voice that says, “Please place the injector on the outerportion of your thigh.” A visual indicator of where the base/injectorshould be placed also can be simultaneously activated. A switch, sensor,or button 9810F then can recognize the correct placement of the device(and the base 1315) and trigger the next audible and visual clue. Thiscan be a voice stating, “Push down on the top of the injector toactivate the injection.” Likewise, an arrow or some other visual and/orhaptic clue can light up and/or be rendered to show the motion of howthe injector should be pushed. The last clue can be an audible clue thatstates, “Hold in place for several seconds, remove, and dispose ofproperly,” indicating that the injection is complete. Additionalaudible, haptic, and/or visual feedback sub-systems can be used toprovide the user with important information such as the expiration ofthe drug, improper use, and/or error. For instance, the device's LEDs oroptics can blink, a display can render a message, a vibrator canvibrate, and/or an audible beep and/or voice can be activated after aparticular time stamp is reached that corresponds to the expiration ofthe drug and/or device. As another example, once an auto-injector hasbeen used, a message can be displayed describing proper disposal and/orrecycling techniques.

FIG. 26 is a block diagram of an exemplary embodiment of an informationsystem and/or device 26000, which in certain operative embodiments cancomprise, for example, the interactive, integral, embedded, audible,haptic, and/or visual feedback system, such as described herein.Information system and/or device 26000 can comprise any of numerouscomponents, such as for example, one or more network interfaces 26100,one or more processors 26200 running an embedded, real-time, hardreal-time, and/or soft real-time operating system, one or more memories26300 containing instructions 26400, one or more input/output (I/O)devices 26500, and/or one or more user interfaces 26600 coupled to I/Odevice 26500, etc.

In certain exemplary embodiments, via one or more user interfaces 26600,such as a graphical user interface, a user can view a rendering ofinformation related to selecting, purchasing, obtaining, operating,maintaining, re-using, and/or disposing of an auto-injector. In certainexemplary embodiments, instructions 26400 can be modified and/or updatedvia replacing a removable memory 26300 and/or via replacing instructions26400 (such as, e.g., via flashing an EEPROM, etc.). In certainexemplary embodiments, instructions 26400 can be modified and/or updatedvia downloading replacement instructions via network interface 26100.System 26000 can comprise a programmable logic controller.

Still other practical and useful embodiments will become readilyapparent to those skilled in this art from reading the above-reciteddetailed description and drawings of certain exemplary embodiments. Itshould be understood that numerous variations, modifications, andadditional embodiments are possible, and accordingly, all suchvariations, modifications, and embodiments are to be regarded as beingwithin the spirit and scope of this application.

Thus, regardless of the content of any portion (e.g., title, field,background, summary, abstract, drawing figure, etc.) of thisapplication, unless clearly specified to the contrary, such as via anexplicit definition, assertion, or argument, with respect to any claim,whether of this application and/or any claim of any application claimingpriority hereto, and whether originally presented or otherwise:

there is no requirement for the inclusion of any particular described orillustrated characteristic, function, activity, or element, anyparticular sequence of activities, or any particular interrelationshipof elements;

any elements can be integrated, segregated, and/or duplicated;

any activity can be repeated, performed by multiple entities, and/orperformed in multiple jurisdictions; and

any activity or element can be specifically excluded, the sequence ofactivities can vary, and/or the interrelationship of elements can vary.

Accordingly, the descriptions and drawings are to be regarded asillustrative in nature, and not as restrictive. Moreover, when anynumber or range is described herein, unless clearly stated otherwise,that number or range is approximate. When any range is described herein,unless clearly stated otherwise, that range includes all values thereinand all subranges therein. Any information in any material (e.g., aUnited States patent, United States patent application, book, article,etc.) that has been incorporated by reference herein, is onlyincorporated by reference to the extent that no conflict exists betweensuch information and the other statements and drawings set forth herein.In the event of such conflict, including a conflict that would renderinvalid any claim herein or seeking priority hereto, then any suchconflicting information in such incorporated by reference material isspecifically not incorporated by reference herein.

What is claimed is:
 1. A method of training a user in an operation of amedical injector, the method comprising: activating an electroniccircuit system to output a recorded speech output, the electroniccircuit system coupled to a housing associated with the medicalinjector, the recorded speech output associated with a firstinstruction; removing a safety lock from the housing, the safety lockconfigured to limit movement of a base when the safety lock is coupledto the housing, a first switch of the electronic circuit system beingactuated when the safety lock is removed, the electronic circuit systemproducing a second instruction when the first switch is actuated;placing, after the removing the safety lock, the base against a targetlocation; and moving, after the placing, the base from a first positionto a second position relative to the housing, a portion of the baseactuating a second switch of the electronic circuit system when the baseis moved to the second position, the electronic circuit system producinga third instruction when the second switch is actuated.
 2. The method oftraining the user in the operation of the medical injector of claim 1,wherein: the activating the electronic circuit system includesmanipulating a button coupled to the housing; and the moving the base isperformed independently from the manipulating the button.
 3. The methodof training the user in the operation of the medical injector of claim1, wherein: the recorded speech output is a first recorded speechoutput; and the second instruction includes a second recorded speechoutput that identifies the base and the target location.
 4. The methodof training the user in the operation of the medical injector of claim1, wherein: the base includes a protrusion configured to retain the basein the second position; and the safety lock includes a protrusion thatseparates the base from the housing to limit movement of the base whenthe safety lock is coupled to the housing.
 5. The method of training theuser in the operation of the medical injector of claim 1, wherein: themedical injector is an epinephrine autoinjector.
 6. The method oftraining the user in the operation of the medical injector of claim 1,wherein: the moving the base causes an energy storage member within thehousing to produce a force to inject a medicament from within amedicament container, the medicament container being within the housing.7. The method of training the user in the operation of the medicalinjector of claim 6, wherein: the portion of the base is a firstportion; and the moving the base causes a second portion of the base torelease an actuation member within the housing, the actuation memberactuating the energy storage member to produce the force when theactuation member is released.
 8. The method of training the user in theoperation of the medical injector of claim 1, wherein: the electroniccircuit system includes a speaker and a light output device; therecorded speech output is a first recorded speech output; and the secondinstruction includes a light output produced by the light output deviceand a second recorded speech output produced by the speaker.
 9. Themethod of training the user in the operation of the medical injector ofclaim 1, wherein: the electronic circuit system includes a memorycomponent and a processor, the memory component storing acomputer-executable instruction associated with any of the firstinstruction the second instruction, or the third instruction; and theprocessor executes the computer-executable instruction when at least oneof the first switch is actuated or the second switch is actuated. 10.The method of training the user in the operation of the medical injectorof claim 1, wherein the activating an electronic circuit system tooutput a recorded speech output includes repeating the recorded speechoutput if the safety lock has not been removed from the housing within apredetermined time.
 11. The method of training the user in the operationof the medical injector of claim 1, wherein: the housing defines astatus window; and the moving the base causes a use indicator to movewithin the housing to a position in which the use indicator is viewablethrough the status window.
 12. A method of training a user in anoperation of a medical injector, the method comprising: activating anelectronic circuit system to output a first use instruction associatedwith the medical injector; removing a safety lock from a housingassociated with the medical injector, the safety lock configured tolimit movement of a base when the safety lock is coupled to the housing,a first switch of the electronic circuit system being actuated when thesafety lock is removed, the electronic circuit system producing a seconduse instruction when the first switch is actuated; placing, after theremoving the safety lock, the base against a target location; andpressing the base against the target location to move the base relativeto the housing from a first position to a second position, a secondswitch of the electronic circuit system being actuated when the base ismoved from the first position to the second position, the electroniccircuit system producing a third use instruction when the second switchis actuated.
 13. The method of training the user in the operation of themedical injector of claim 12, wherein: the electronic circuit systemincludes a speaker and a light output device; and any of the first useinstruction, the second use instruction, or the third use instructionincludes a light output produced by the light output device and arecorded speech output produced by the speaker.
 14. The method oftraining the user in the operation of the medical injector of claim 12,wherein: the electronic circuit system includes a memory component and aprocessor, the memory component storing a computer-executableinstruction associated with any of the first use instruction, the seconduse instruction, or the third use instruction; and the processorexecutes the computer-executable instruction when at least one of thefirst switch or the second switch is actuated.
 15. The method oftraining the user in the operation of the medical injector of claim 14,wherein the electronic circuit system includes a network interface, themethod further comprising: updating the computer-executable instructionvia network interface.
 16. The method of training the user in theoperation of the medical injector of claim 12, wherein the activating anelectronic circuit system to output the first use instruction includesrepeating the first use instruction output if the safety lock has notbeen removed from the housing within a predetermined time.
 17. Themethod of training the user in the operation of the medical injector ofclaim 12, wherein: the housing defines a status window; and the movingthe base causes a use indicator to move within the housing to a positionin which the use indicator is viewable through the status window. 18.The method of training the user in the operation of the medical injectorof claim 12, wherein: the moving the base causes an energy storagemember within the housing to produce a force to inject a medicament fromwithin a medicament container, the medicament container being within thehousing.
 19. The method of training the user in the operation of themedical injector of claim 18, wherein the moving the base causes aportion of the base to release an actuation member within the housing,the actuation member actuating the energy storage member to produce theforce when the actuation member is released.
 20. The method of trainingthe user in the operation of the medical injector of claim 1, wherein:the base includes a protrusion configured to retain the base in thesecond position.
 21. The method of training the user in the operation ofthe medical injector of claim 1, wherein: the base is disposed at adistal end portion of the housing.
 22. The method of training the userin the operation of the medical injector of claim 1, wherein: the movingthe base includes moving the base linearly relative to the housing. 23.The method of training the user in the operation of the medical injectorof claim 12, wherein: the base includes a protrusion configured toretain the base in the second position.
 24. The method of training theuser in the operation of the medical injector of claim 12, wherein: thebase is disposed at a distal end portion of the housing.
 25. The methodof training the user in the operation of the medical injector of claim12, wherein: the moving the base includes moving the base linearlyrelative to the housing.